BridgeMD
New treatment option for Ulcerative Colitis
Official title Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
ClinicalTrials.gov ID: NCT06937086
What this study is testing
What is Mirikizumab?
Mirikizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ulcerative colitis.
Also referred to as LY3074828.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that...
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by...
- Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to...
- Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]
- Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
You likely can't join if
- Have a current diagnosis of:
- Crohn's disease
- inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis.
- Have had or will need bowel resection or intestinal or intra-abdominal surgery.
- Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
See the full eligibility criteria
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
- Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and...
- Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]
- Have overweight (BMI ≥27 kg/m2 to \<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:
- hypertension
- Type 2 Diabetes Mellitus (T2DM)
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease.
- Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for...
- Have a current diagnosis of:
- Crohn's disease
- inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis.
- Have had or will need bowel resection or intestinal or intra-abdominal surgery.
- Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
- Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
- Have a current or recent acute, active infection.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Los Alamitos, California, United States
- Northridge, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Sunrise, Florida, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- New Albany, Indiana, United States
- Louisville, Kentucky, United States
- New Iberia, Louisiana, United States
- Shreveport, Louisiana, United States
- Chevy Chase, Maryland, United States
- New Bedford, Massachusetts, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
+ 145 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Anaheim, California, United States; Beverly Hills, California, United States; Los Alamitos, California, United States; Northridge, California, United States; Miami, Florida, United States and 159 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.